Extended Open Challenge in Patients With a History of Drug Eruption Following Beta-lactam Treatment
Beta-lactam allergy is the most prevalent drug allergy. Drug eruption is the most common symptom whereas life-threatening anaphylaxis is rather rare. A recently published study (Journal of Allergy and Clinical Immunology, January 2011, Vol. 127, p. 218-222) described the safety of a 2-day oral beta-lactam challenge in penicillin-allergic patients, disregarding their penicillin skin test results. In the proposed study the investigators will similarly challenge beta-lactam allergic patients, both children and adults for an extended (5 days) period of time. The study will include patients with a history of a skin rash following beta-lactam administration as well as patients who cannot provide any data on their presumed allergic reaction, disregarding their penicillin skin test results.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
- The safety of a 5-day oral challenge in patients with suspected beta-lactam allergy [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]In case of the development of any adverse reactions throughout the 5-day challenge patients will notify the investigators over the phone. If assessed necessary by the investigators, patients will return to the Allergy Clinic for repeated evaluation. After completion of the 5-day challenge all patients will be contacted by the investigators and will be inquired about any adverse reactions throughout the challenge. The number of participants with adverse reactions to the challenge will be reported.
|Study Start Date:||March 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Drug: Beta-lactam oral challenge
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520181
|Contact: Arnon Goldberg, MDemail@example.com|
|Arnon Goldberg, Allergy and Clinical Unit, Meir Medical Center||Recruiting|
|Kfar-Saba, Israel, 44281|
|Contact: Arnon Goldberg, M.D. 972-9-7472717 firstname.lastname@example.org|
|Principal Investigator: Arnon Goldberg, M.D.|